Drug Topics- August 11, 2008

48 DRUG TOPICS AUGUST 11, 2008 www.drugtopics.com Self-Care Featured this month: Head lice New products bring lice treatment to a head Dana K. Cassell Egg Hair I t has been 22 years since the Food and Drug Administration (FDA) last approved a new prescription drug treatment (permethrin [Nix]) for head lice, but anxious parents can now look forward to several new Rx remedies. In addition, a number of new OTC products are primed for the upcoming louse “busy season.” What’s new • Sciele Pharma expects to release the first nonpesticide prescription treatment for head lice by the end of September. The product name is not yet approved. Originally named Pyxxlice, the pending name is LARx. A lice asphyxiator, the Sciele product is a lotion with an active ingredient of 5% benzyl alcohol. How does it work? Lice, which need oxygen to live, breathe through sophisticated spiracles. This product prevents lice from closing their spiracles, thereby asphyxiating the lice within 10 minutes. • LiceMD is Combe’s new dimethicone-based, pesticide-free liquid gel, which makes it easier to comb through even the thickest, curliest hair to remove adult lice, nits (eggs), and nymphs (hatchlings). The LiceMD Web site offers consumers a “How to Comb” video. • The latest edition to Health Enterprise’s lice care line is an Acu-Life Lice Comb 2 Pack, featuring a long-pin comb for nits and a short-pin comb for lice. • To celebrate the 10th anniversary of Licefreee!, Tec Labs now includes a howto-use DVD with the Licefreee! kit. • Australia’s Wild Child, a natural health care products company, in January introduced Quit Nits head lice products to the United States, with distribution through CVS Pharmacies. The Quit Nits product line includes a treatment cream and preventative spray, both made from plant oils originating in the Australian outback. The cream is reported to work by smothering the louse and interrupting its breathing cycle; the spray works by inhibiting the maturation of eggs and nymphs. Roland Bydlon, director of marketing, told Drug Topics, “The product is currently in phase III trials. Our goal is to have the product out in 2009.” The active ingredient for NatrOVA is Spinosad, an organic insecticide developed by Eli Lilly, that excites the nervous system of the louse, causing the insect to die of exhaustion. • Manhattan Pharmaceuticals is developing Hedrin as a medical device. Although it is a liquid formulation, it works solely on the louse and does not affect the structure or function of the human skin or hair. Thus, there is no combing involved. Hedrin is comprised of two different silicones mixed together. Cyclomethicone, the lighter one, carries the heavy dimethicone across the hair and across the lice, then evaporates, leaving the heavier one to clog the lice’s spiracles. Hedrin is left on the patient’s head overnight, then shampooed out in the morning. The approval timeline is unclear but likely is anywhere from six to 18 months away. What’s in the future • Piedmont Pharmaceuticals has completed clinical work for Resultz, an insecticide-free pediculicide rinse. Resultz works by dissolving the waxy covering of a louse’s exoskeleton, exposing its circulatory system. Within about 10 minutes of application, lice begin to dehydrate and die. Resultz is currently available in Canada and the United Kingdom and must now work through the FDA regulatory process. • Topaz Pharmaceuticals has completed phase I trials of ivermectin, a broad-spectrum antiparasitic compound. In one study ivermectin proved 100% effective at killing a strain of head lice that had shown resistance to permethrin, the active ingredient in many OTC treatments. Ivermectin is reported to be non-toxic and to work by targeting the lice’s nervous systems and muscles, literally causing them to fall off the hair. FDA approval is expected to take another two to three years. • Bayer is in the “very preliminary” stages of developing new additions to its Rid product line. A spokesperson said the company has some set up for 2009 and 2010, “but right now it’s too premature to talk about them.” More information on lice and the misconceptions surrounding them can be found under Web Exclusives on www.drugtopics.com. THE AUTHOR is a writer based in New Hampshire. What’s around the corner • NatrOVA is the proposed name for a prescription topical cream rinse being developed by ParaPRO. http://www.drugtopics.com http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics- August 11, 2008

Drug Topics- August 11, 2008 Contents Latebreakers Letters DEA Proposes Rule To Allow Electronic Prescriptions for Controlled Substances Merger, Medicare Reform Could Mean Broader E-Prescribing Adoption New Combination Pill Approved for Type 2 Diabetes New Eczema Guildlines Promote Use of Emollients, Then Topical Corticosteroids Agencies Flush Original Strategies in Favor of Promoting Drug Take-Back Programs JP at Large: You Laughing at Me? Pharmacists Find Themselves at Mercy of Prior Authorization State Law Requiring PBM Transparency See Some Gains, Some Losses Global Counterfeiting Still Growing, Says U.S. Commerce Official FDA Saftey Page: Prophylthiouracil Still Confused with Purinethol (mercaptopurine) New Products Bring Lice Treatment to a Head NACDS Marketplace Showcases New Product that Fill Unmet Needs Update on Respiratory Tract Infections Execs Share War Stories About Adopting Technology in their Stores New Products Advertisters Index Classified Viewpoint: Medicare Part D Revisions sorely needed

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